Total30 Multifocal Toric Contact Lenses in Presbyopic Toric Wearers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will refit healthy adults aged 40 and older who currently wear reusable silicone hydrogel toric contact lenses into Total30 MFT toric lenses and follow them for one month to assess comfort and willingness to continue lens wear. Primary outcomes include the proportion of participants with positive comfort and vision scores after one month and the Dry Eye Questionnaire-8 score as a measure of comfort. The trial uses a single-arm design over 29 days with in-person wear and periodic text-based assessments to gauge comfort, vision, satisfaction, and adherence. The intervention is Total30 Multifocal Toric contact lenses worn daily for at least 13-16 hours on specified days. The sponsor is the Southern College of Optometry, located in Memphis, TN.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults, ≥40-year-old, CL wearers with best-corrected 20/20 distance visual acuity or better.
* Requiring +0.75 ADD or more at standard near distance of 40 cm.
* Participants will be required to have worn reusable silicone hydrogel toric CLs in the past year and still at a minimum wearing the CLs occasionally without having significant discomfort or dryness.
* All participants will be required to have a CLDEQ-8 score \<12.
* Participants will be required to be able to wear Total 30MFT CLs (presbyopic plus astigmatism both ≥0.75D OD and OS).
* Astigmatism ranging from 0.75 D to 2.50 D in each eye.
* Participants will be required to wear the study CLs for ≥13 hours each day with no overnight wear.
* Willing to wear study CLs for ≥16 hours on the Day 1 (1st full day), Day 14, and Day 29 when responses will be collected via text message.
* Participants will be willing to wear the CL every day of the week.
* Participants will be required to provide a glasses prescription that is less than 3 years old.
* Visual acuity with habitual reusable silicone hydrogel toric CLs is 20/25 or better in each eye.

Exclusion Criteria:

* Have worn Total30 MFT in the past
* Are past rigid CL wearers
* Are currently wearing monovision CLs
* Have a history of being diagnosed with dry eye or ocular allergies
* Have known systemic health conditions that are thought to alter tear film physiology
* Have a history of viral eye disease
* Have a history of ocular surgery
* Have a history of severe ocular trauma
* Have a history of corneal dystrophies or degenerations
* Have active ocular infection or inflammation
* Are currently using isotretinoin-derivatives or ocular medications
* Are pregnant or breast feeding

Where it's running

• The Southern College of Optometry
  Memphis, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Chris Lievens, OD
• Email: clievens@sco.edu
• Phone: (901) 722-3200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.